50 Mg/2Ml Solution for Injection/Infusion

Total Page:16

File Type:pdf, Size:1020Kb

50 Mg/2Ml Solution for Injection/Infusion SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Product name> 50 mg/2ml solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains dexketoprofen trometamol corresponding to 25 mg of dexketoprofen. One ampoule (2 ml) contains dexketoprofen trometamol corresponding to 50 mg of dexketoprofen. Excipients with known effect: 200 mg ethanol (96 %) and 8.0 mg sodium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear colourless solution, free from visible particles. pH 7.0-8.0 Osmolarity 270-328 mOsmol/l 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain. 4.2 Posology and method of administration Posology Adults The recommended dose is 50 mg every 8 – 12 hours. If necessary, the administration can be repeated 6 hours apart. The total daily dose should not exceed 150 mg. <Product name> is intended for short term use and the treatment must be limited to the acute symptomatic period (no more than two days). Patients should be switched to an oral analgesic treatment when possible. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). In case of moderate to severe postoperative pain, <Product name> can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults (see section 5.1). Pediatric population <Product name> has not been studied in children and adolescents. Therefore the safety and efficacy of <Product name> in children and adolescents have not been established and the medicine should not be used in children and adolescents. Elderly No dosage adjustment is generally necessary in older patients. However because of the physiological decline in renal function in elderly patients a lower dose is recommended in case of mild renal function impairment: 50 mg total daily dose (see section 4.4). Hepatic dysfunction The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate (Child-Pugh score 5 - 9) hepatic impairment and hepatic function should be closely monitored (see section 4.4). <Product name> should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10 - 15) (see section 4.3). Renal dysfunction The dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60 - 89 ml / min) (see section 4.4). <Product name> should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml / min) (see section 4.3). Method of administration <Product name> can be administered either by intramuscular or by intravenous route: - Intramuscular use: the content of one ampoule (2 ml) of <Product name> should be administered by slow injection deep into the muscle. - Intravenous use: - Intravenous infusion: the diluted solution, prepared as described in section 6.6, should be administered as a slow intravenous infusion, lasting 10 to 30 min. The solution must be always protected from natural daylight. - Intravenous bolus: if necessary, the content of one ampoule (2 ml) of <Product name> can be administered in a slow intravenous bolus over no less than 15 seconds. Instructions on handling the product When <Product name> is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the ampoule (see also sections 6.2 and 6.6). For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight (see also section 6.3 and 6.6). For instructions on dilution of the medicinal product before administration, see section 6.6. 4.3 Contraindications <Product name> must not be administered in the following cases: - patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - patients in whom substances with a similar action (e.g. acetylsalicylic acid and other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioedema; - known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates; - patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; - patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding, ulceration or perforation; - patients with chronic dyspepsia; - patients who have other active bleeding or bleeding disorders; - patients with Crohn's disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min); - patients with severely impaired hepatic function (Child-Pugh score 10 - 15); - patients with haemorrhagic diathesis and other coagulation disorders; - patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake); - during the third trimester of pregnancy and lactation period (see section 4.6). <Product name> is contraindicated for neuraxial (intrathecal or epidural) administration due to its ethanol content. 4.4 Special warnings and precautions for use Administer with caution in patients with a history of allergic conditions. The use of <Product name> with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and gastrointestinal and cardiovascular risks below). Gastrointestinal safety Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs in patients receiving <Product name>, the treatment should be withdrawn. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in older people. The older people have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). These patients should commence treatment on the lowest dose available. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see section 4.8). As with all NSAIDs, any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with dexketoprofen trometamol. Patients with gastrointestinal symptoms or history of gastrointestinal disease should be monitored for digestive disturbances, especially gastrointestinal bleeding. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other medicines likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin- reuptake inhibitors or anti-platelet agents (such as aspirin) (see section 4.5). Renal Safety Caution should be exercised in patients with impairment of renal functions. In these patients, the use of NSAIDs may result in deterioration of renal function, fluid retention and oedema. Caution is also required in patients receiving diuretic therapy or those who could develop hypovolaemia as there is an increased risk of nephrotoxicity. Adequate fluid intake should be ensured during treatment to prevent dehydration and possibly associated increased renal toxicity. As with all NSAIDs, it can increase plasma urea nitrogen and creatinine. As with other inhibitors of prostaglandin synthesis, it can be associated with adverse effects on the renal system, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Older patients are more likely to be suffering from impaired renal function (see section 4.2). Liver Safety Caution should be exercised in patients with impairment of hepatic functions. As with other NSAIDs, it can cause transient small increases in some liver parameters, and also significant increases in SGOT and SGPT. In case of a relevant increase in such parameters, therapy must be discontinued. Older patients are more likely to be suffering from impaired hepatic function (see section 4.2). Cardiovascular and cerebrovascular safety Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID
Recommended publications
  • Development and Validation of an Ultra Performance Liquid
    DOI: 10.4274/tjps.76588 Turk J Pharm Sci 2017;14(1):1-8 ORIGINAL ARTICLE Development and Validation of an Ultra Performance Liquid Chromatography Method for the Determination of Dexketoprofen Trometamol, Salicylic Acid and Diclofenac Sodium Deksketoprofen Trometamol, Salisilik Asit ve Diklofenak Sodyum Etkin Maddeleri için Ultra Performanslı Sıvı Kromatografisi Yönteminin Geliştirilmesi ve Validasyonu Sibel İLBASMIŞ TAMER Gazi University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey ABSTRACT Objectives: A simple, fast, accurate and precise method has been developed for the determination of dexketoprofen trometamol (DKP), salicylic acid (SA) and diclofenac sodium (DIC) in the drug solutions using ultra high performance liquid chromatography (UPLC). Materials and Methods: UPLC method is highly reliable and sensitive method to quantify the amount of the active ingredient and the method is validated according to ICH guidelines. Results: The developed method is found to be precise, accurate, specific and selective. The method was also found to be linear and reproducible. The value of limit of dedection (LOD) of DKP, SA, DIC were found 0.00325 µg/mL, 0.0027 µg/mL and 0.0304 µg/mL, respectively. The limit of quantitation (LOQ) of DKP, SA and DIC were found 0.00985 µg/mL, 0.0081 µg/mL and 0.0920 µg/mL, respectively. Conclusion: Proposed methods can be successfully applicable to the pharmaceutical preparation containing the above mentioned drugs (dexketoprofen trometamol, salicylic acid and diclofenac sodium). Even very small amounts of active substance can be analyzed and validations can be performed easily. Key words: Dexketoprofen trometamol, salicylic acid, diclofenac sodium, UPLC, validation ÖZ Amaç: Deksketoprofen trometamol (DKP), salisilik asit (SA) ve diklofenak sodyumun (DIC) ilaç çözeltisindeki analizi için ultra yüksek basınçlı sıvı kromatografisi (UPLC) kullanılarak basit, hızlı, doğru ve kesin bir yöntem geliştirilmiştir.
    [Show full text]
  • Ataxia Caused by a Single Dose of Dexketoprofen Trometamol
    Acta Biomed 2014; Vol. 85, N. 3: 269-270 © Mattioli 1885 Case report Ataxia caused by a single dose of dexketoprofen trometamol Sema Avcı, Selim Genç, Macit Aydın, Fatih Büyükcam, Seda Özkan Department of Emergency Medicine, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey Summary. Mushroom poisoning is an important reason of plant toxicity. Wild mushrooms that gathered from pastures and forests can be dangerous for human health. The clinical outcomes and symptoms of mushroom toxicity vary from mild gastrointestinal symptoms to acute multiple organ failure. Toxic effects to kidney and liver of amatoxin are common but cardiotoxic effects are unusual. In this case, we reported the cardiotoxic effect of amatoxin with the elevated troponin-I without any additional finding in electrocardiography, echo- cardiography and angiography Key words: cardiac enzyme, mushroom, poisoning, toxicity, troponin Introduction ture: 37.1ºC, hearth rate:75 beats/min. On physical examination, the patient was oriented, alert and con- Dexketoprofen trometamol is one of the non- scious. Neurological examination was normal except steroid anti-inflamatory drugs (NSAID) used as an- ataxia and dysarthria. She has no previous chronic dis- algesic (1). It is a water-soluable molecule and it is an eases. Laboratory results were as follows; glucose:102 active enantiomer of racemic ketoprofen (1). Peroral mg/dL, creatinine:0.61 mg/dl, alanine aminotransfer- dexketoprofen has considerable analgesic potency and ase (ALT): 8 U/L , aspartate aminotransferase (AST): well-tolerated adverse effects in patients who suffer 12 U/L, calcium:9.7 mg/dL, sodium:143 mEq/L, from acute and chronic pain (1).
    [Show full text]
  • A Combined Crystallographic and Computational Study on Dexketoprofen Trometamol Dihydrate Salt
    crystals Article A Combined Crystallographic and Computational Study on Dexketoprofen Trometamol Dihydrate Salt Patrizia Rossi 1 , Paola Paoli 1,* , Stella Milazzo 1, Laura Chelazzi 2 , Maria Paola Giovannoni 3, Gabriella Guerrini 3 , Andrea Ienco 4,* , Maurizio Valleri 5 and Luca Conti 6 1 Department of Industrial Engineering, University of Florence, via Santa Marta 3, 50139 Florence, Italy; p.rossi@unifi.it (P.R.); stella.milazzo@unifi.it (S.M.) 2 Centro di Cristallografia Strutturale, University of Florence, via della Lastruccia 3, Sesto F.no, 50019 Florence, Italy; laura.chelazzi@unifi.it 3 NEUROFARBA, Sezione Farmaceutica e Nutraceutica, University of Florence, Via Ugo Schiff 6, Sesto F.no, 50019 Florence, Italy; mariapaola.giovannoni@unifi.it (M.P.G.); gabriella.guerrini@unifi.it (G.G.) 4 CNR-ICCOM, via Madonna del Piano 10, Sesto F.no, 50019 Florence, Italy 5 A. Menarini Manufacturing Logistics and Services s.r.l., via R. Pilo 4, 50131 Florence, Italy; [email protected] 6 Department of Chemistry “U. Schiff”, University of Florence, via della Lastruccia 3, Sesto F.no, 50019 Florence, Italy; luca.conti@unifi.it * Correspondence: paola.paoli@unifi.it (P.P.); [email protected] (A.I.) Received: 29 June 2020; Accepted: 30 July 2020; Published: 31 July 2020 Abstract: Dexketoprofen trometamol is the tromethamine salt of dexketoprofen [(2S)-2-(3-benzoylphenyl) propanoic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol], a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of moderate- to strong-intensity acute pain. The crystal structure of the hitherto sole known hydrate phase of dexketoprofen trometamol (DK-T_2H2O), as determined by single-crystal X-ray diffraction, is presented.
    [Show full text]
  • Package Leaflet: Information for the Patient Dexketoprofen Rowex 25 Mg Film-Coated Tablets Dexketoprofen
    Package leaflet: Information for the patient Dexketoprofen Rowex 25 mg Film-coated tablets Dexketoprofen Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Dexketoprofen Rowex is and what it is used for 2. What you need to know before you take Dexketoprofen Rowex 3. How to take Dexketoprofen Rowex 4. Possible side effects 5. How to store Dexketoprofen Rowex 6. Contents of the pack and other information 1. What Dexketoprofen Rowex is and what it is used for Dexketoprofen Rowex is a pain killer from the group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache. 2. What you need to know before you take Dexketoprofen Rowex Do not take Dexketoprofen Rowex if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6). are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines. have asthma or have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines.
    [Show full text]
  • Treatment for Acute Pain: an Evidence Map Technical Brief Number 33
    Technical Brief Number 33 R Treatment for Acute Pain: An Evidence Map Technical Brief Number 33 Treatment for Acute Pain: An Evidence Map Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2015-0000-81 Prepared by: Minnesota Evidence-based Practice Center Minneapolis, MN Investigators: Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Victoria A. Nelson, M.Sc. Shellina Scheiner, PharmD, B.C.G.P. Mary L. Forte, Ph.D., D.C. Mary Butler, Ph.D., M.B.A. Sanket Nagarkar, D.D.S., M.P.H. Jayati Saha, Ph.D. Timothy J. Wilt, M.D., M.P.H. AHRQ Publication No. 19(20)-EHC022-EF October 2019 Key Messages Purpose of review The purpose of this evidence map is to provide a high-level overview of the current guidelines and systematic reviews on pharmacologic and nonpharmacologic treatments for acute pain. We map the evidence for several acute pain conditions including postoperative pain, dental pain, neck pain, back pain, renal colic, acute migraine, and sickle cell crisis. Improved understanding of the interventions studied for each of these acute pain conditions will provide insight on which topics are ready for comprehensive comparative effectiveness review. Key messages • Few systematic reviews provide a comprehensive rigorous assessment of all potential interventions, including nondrug interventions, to treat pain attributable to each acute pain condition. Acute pain conditions that may need a comprehensive systematic review or overview of systematic reviews include postoperative postdischarge pain, acute back pain, acute neck pain, renal colic, and acute migraine.
    [Show full text]
  • Nonsteroidal Anti-Inflammatory Drugs for Dysmenorrhoea (Review)
    Cochrane Database of Systematic Reviews Nonsteroidal anti-inflammatory drugs for dysmenorrhoea (Review) Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD001751. DOI: 10.1002/14651858.CD001751.pub3. www.cochranelibrary.com Nonsteroidal anti-inflammatory drugs for dysmenorrhoea (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 5 OBJECTIVES ..................................... 6 METHODS ...................................... 6 Figure1. ..................................... 8 Figure2. ..................................... 10 Figure3. ..................................... 12 RESULTS....................................... 14 Figure4. ..................................... 16 Figure5. ..................................... 18 Figure6. ..................................... 24 ADDITIONALSUMMARYOFFINDINGS . 25 DISCUSSION ..................................... 26 AUTHORS’CONCLUSIONS . 27 ACKNOWLEDGEMENTS . 27 REFERENCES ..................................... 28 CHARACTERISTICSOFSTUDIES . 40 DATAANDANALYSES. 130 Analysis 1.1. Comparison 1 NSAIDs vs placebo, Outcome 1 Pain relief dichotomous data. 136
    [Show full text]
  • Inflammatory Drugs (Nsaids) for People with Or at Risk of COVID-19
    Evidence review Acute use of non-steroidal anti- inflammatory drugs (NSAIDs) for people with or at risk of COVID-19 Publication date: April 2020 This evidence review sets out the best available evidence on acute use of non- steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19. It should be read in conjunction with the evidence summary, which gives the key messages. Evidence review commissioned by NHS England Disclaimer The content of this evidence review was up-to-date on 24 March 2020. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. For details on the date the searches for evidence were conducted see the search strategy. Copyright © NICE 2020. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3763-9 Contents Contents ...................................................................................................... 1 Background ................................................................................................. 2 Intervention .................................................................................................. 2 Clinical problem ........................................................................................... 3 Objective ...................................................................................................... 3 Methodology ................................................................................................ 4 Summary of included studies
    [Show full text]
  • Aspirin Suppresses the Growth and Metastasis of Osteosarcoma
    Published OnlineFirst July 22, 2015; DOI: 10.1158/1078-0432.CCR-15-0198 Cancer Therapy: Preclinical Clinical Cancer Research Aspirin Suppresses the Growth and Metastasis of Osteosarcoma through the NF-kB Pathway Dan Liao, Li Zhong, Tingmei Duan, Ru-Hua Zhang, Xin Wang, Gang Wang, Kaishun Hu, Xiaobin Lv, and Tiebang Kang Abstract Purpose: Aspirin has recently been reported to reduce both t test or ANOVA with the Bonferroni post hoc test were used for the the incidence and the risk of metastasis in colon cancer. statistical comparisons. However, there is no evidence at the cellular levels or in the Results: Aspirin reduced cell viability in a dose- and time- animal models for such an effect of aspirin on cancer dependent manner in osteosarcoma cell lines, and aspirin syn- metastasis. ergistically sensitized osteosarcoma cells to cisplatin (DDP) Experimental Design: MTT assay, colony formation assay, and in vitro and in vivo (P < 0.001). Moreover, aspirin markedly apoptosis assay were employed to analyze the effects of aspirin on repressed the migration and invasion of osteosarcoma cells the osteosarcoma cell viability in vitro. The NF-kB activity was in vitro (P < 0.001), and dramatically diminished the occurrence measured by the NF-kB p65 luciferase reporter. Western blotting of osteosarcoma xenograft metastases to the lungs in vivo was used to analyze the proteins in cells. The migration and (P < 0.001). Mechanistically, aspirin diminishes osteosarcoma invasion abilities of osteosarcoma cells in vitro were measured migration, invasion, and metastasis through the NF-kB pathway. by the Transwell assay. Xenograft-bearing mice were used to assess Conclusion: Aspirin suppresses both the growth and metasta- the roles of aspirin in both tumor growth and metastasis of sis of osteosarcoma through the NF-kB pathway at the cellular osteosarcoma in vivo (n ¼ 5–8 mice/group).
    [Show full text]
  • Pengaruh Dexketoprofen Dengan Ketorolac Terhadap Kadar Kortisol Plasma Pada Tikus Wistar Yang Mengalami Insisi
    PENGARUH DEXKETOPROFEN DENGAN KETOROLAC TERHADAP KADAR KORTISOL PLASMA PADA TIKUS WISTAR YANG MENGALAMI INSISI JURNAL MEDIA MEDIKA MUDA Disusun untuk memenuhi sebagian persyaratan guna mencapai strata 1 Kedokteran Umum Disusun oleh: DEVINA ADIYANI PRANOWO 22010110110060 PROGRAM PENDIDIKAN SARJANA KEDOKTERAN FAKULTAS KEDOKTERAN UNIVERSITAS DIPONEGORO 2014 PENGARUH DEXKETOPROFEN DENGAN KETOROLAC TERHADAP KADAR KORTISOL PLASMA PADA TIKUS WISTAR YANG MENGALAMI INSISI DEVINA ADIYANI PRANOWO ABSTRAK Latar belakang: Luka pasca pembedahan seperti insisi dapat menimbulkan nyeri yang akan merangsang timbulnya respon stress metabolik (MSR) berupa peningkatan kadar kortisol. Meningkatnya kadar kortisol menyebabkan penekanan respon imun dan melambatnya penyembuhan luka. Pemberian Dexketoprofen dan Ketorolac akan mengurangi rasa nyeri yang berefek pada penurunan kadar kortisol dan mempercepat penyembuhan luka. Tujuan: Membuktikan adanya perbedaan pengaruh Dexketoprofen intramuskular dengan Ketorolac intramuskular terhadap kadar kortisol plasma pada tikus wistar yang mengalami insisi. Metode: Penelitian eksperimental dengan desain Randomize Post test only control group design. Penelitian menggunakan hewan coba tikus wistar sejumlah 10 ekor yang diambil dengan randomisasi yang memenuhi kriteria inklusi dan ekslusi. 10 ekor tikus wistar dibagi menjadi 2 kelompok masing- masing 5 ekor, Kelompok yang I (K I) akan diinsisi sepanjang 2cm dan diinjeksi Dexketoprofen intramuskular 0,225 mg setiap 6 jam selama 24 jam , Kelompk yang ke II (K II) akan diinsisi sepanjang 2cm dan diinjeksi Ketorolac intramuskular 0,54 mg setiap 6jam selama 24 jam. Pemeriksaan kadar Kortisol dilakukan 24 jam pasca insisi dengan sistem Immune Cortisol dan dibaca dengan perangkat ELISA reader. Hasil: Kadar kortisol plasma pada kelompok K I (Dexketoprofen) lebih rendah dibandingkan K II (Ketorolac) dan berdasarkan uji statistik didapatkan p = 0,006 yang berarti terdapat perbedaan yang bermakna ( p < 0,005) pada penurunan kadar kortisol plasma antara kelompok K I (Dexketoprofen) dengan K II (Ketorolac).
    [Show full text]
  • Dexketoprofen Pharmacare 25 Mg Film-Coated Tablets Dexketoprofen
    Package leaflet: Information for the patient Dexketoprofen Pharmacare 25 mg film-coated tablets Dexketoprofen Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Dexketoprofen Pharmacare is and what it is used for 2. What you need to know before you take Dexketoprofen Pharmacare 3. How to take Dexketoprofen Pharmacare 4. Possible side effects 5. How to store Dexketoprofen Pharmacare 6. Contents of the pack and other information 1. What Dexketoprofen Pharmacare is and what it is used for Dexketoprofen Pharmacare is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache. 2. What you need to know before you take Dexketoprofen Pharmacare Do not take Dexketoprofen Pharmacare: If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6); If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines;
    [Show full text]
  • Prescription Medications, Drugs, Herbs & Chemicals Associated With
    Prescription Medications, Drugs, Herbs & Chemicals Associated with Tinnitus American Tinnitus Association Prescription Medications, Drugs, Herbs & Chemicals Associated with Tinnitus All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, or by any means, without the prior written permission of the American Tinnitus Association. ©2013 American Tinnitus Association Prescription Medications, Drugs, Herbs & Chemicals Associated with Tinnitus American Tinnitus Association This document is to be utilized as a conversation tool with your health care provider and is by no means a “complete” listing. Anyone reading this list of ototoxic drugs is strongly advised NOT to discontinue taking any prescribed medication without first contacting the prescribing physician. Just because a drug is listed does not mean that you will automatically get tinnitus, or exacerbate exisiting tinnitus, if you take it. A few will, but many will not. Whether or not you eperience tinnitus after taking one of the listed drugs or herbals, or after being exposed to one of the listed chemicals, depends on many factors ‐ such as your own body chemistry, your sensitivity to drugs, the dose you take, or the length of time you take the drug. It is important to note that there may be drugs NOT listed here that could still cause tinnitus. Although this list is one of the most complete listings of drugs associated with tinnitus, no list of this kind can ever be totally complete – therefore use it as a guide and resource, but do not take it as the final word. The drug brand name is italicized and is followed by the generic drug name in bold.
    [Show full text]
  • Oral Nonsteroidal Anti-Inflammatory Drugs for Neuropathic Pain
    Oral nonsteroidal anti-inflammatory drugs for neuropathic pain (Review) Moore RA, Chi CC, Wiffen PJ, Derry S, Rice ASC This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 10 http://www.thecochranelibrary.com Oral nonsteroidal anti-inflammatory drugs for neuropathic pain (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 4 METHODS ...................................... 4 RESULTS....................................... 7 Figure1. ..................................... 8 Figure2. ..................................... 9 DISCUSSION ..................................... 10 AUTHORS’CONCLUSIONS . 11 ACKNOWLEDGEMENTS . 11 REFERENCES ..................................... 12 CHARACTERISTICSOFSTUDIES . 16 DATAANDANALYSES. 20 APPENDICES ..................................... 20 WHAT’SNEW..................................... 25 HISTORY....................................... 25 CONTRIBUTIONSOFAUTHORS . 25 DECLARATIONSOFINTEREST . 26 SOURCESOFSUPPORT . 26 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 26 NOTES........................................ 26 Oral nonsteroidal anti-inflammatory drugs for neuropathic pain (Review) i Copyright © 2015 The Cochrane Collaboration. Published by John Wiley
    [Show full text]